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A Study to Evaluate LY06006 and Prolia in Healthy Adults

NCT04973722 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2021-07-22

No results posted yet for this study

Summary

A randomized, double-blind, parallel-group study in Chinese healthy male subjects to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY06006 versus Prolia following single-dose subcutaneous injection

Conditions

  • Healthy Adults

Interventions

DRUG

LY06006

60 mg/1 ml, once every 6 months administered subcutaneously

DRUG

Prolia

60 mg/1 ml, once every 6 months administered subcutaneously

Sponsors & Collaborators

  • Shan Dong Boan Biotechnology Co., Ltd

    collaborator UNKNOWN

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Principal Investigators

  • Guoping Yang, doctor · The Third Xiangya Hospital of Central South University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-09
Primary Completion
2021-04-10
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04973722 on ClinicalTrials.gov